Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to
FDA device recall Z-1734-2024 · posted 2024-05-01 · Open, Classified
Recall details
- Recalling firm
- Noah Medical
- Reason for recall
- Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
- Action taken
- On 03/09-11/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx overnight to customers informing them that due to an misalignment calibration of wired controller, it potentially could cause unintended motion of the Galaxy bronchoscope. Customers are instructed to: -Not utilize any of the wired controllers -Remove from service -Return to Noah Medical For any questions, contact Customer Service at 888-325-6624, ext. 3
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 17 wired controllers
- Distribution
- U.S. Nationwide distribution in the states of CA, IN, MD, MO, OH, and PA.
- Date initiated
- 2024-03-09
- Date posted
- 2024-05-01
- Location
- San Carlos, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Galaxy System (K223144) | Noah Medical Corp. | 2023-03-01 |